Tazocin EF Special Precautions

Serious and occasionally fatal hypersensitivity reactions including anaphylactoid and severe cutaneous adverse reactions have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with piperacillin/tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, piperacillin/tazobactam must be discontinued immediately and appropriate alternative therapy instituted. Not to be used in patients with known hypersensitivity to penicillin.
Piperacillin/tazobactam may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (see Adverse Reactions). If patients develop a skin rash, they should be monitored closely and piperacillin/tazobactam discontinued if lesions progress.
Rare cases of haemophagocytic lymphohistiocytosis (HLH) have been observed following therapy (>10 days) with piperacillin/tazobactam, often as a complication of DRESS. HLH is a pathologic immune activation which leads to excessive systemic inflammation and can be life-threatening and early diagnosis and rapid initiation of immunosuppressive therapy is essential. Characteristic signs and symptoms include fever, hepatosplenomegaly, cytopenias, hyperferritinaemia, hypertriglyceridaemia, hypofibrinogenaemia, and haemophagocytosis. If piperacillin/tazobactam is suspected as possible trigger, treatment should be discontinued.
Antibiotic-induced pseudomembranous colitis may manifest as severe, persistent diarrhea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Bleeding manifestations have occurred in some patients receiving β-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure (see Interactions). If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
This product contains 2.84 mEq (65 mg) of sodium per gram of piperacillin which may increase a patient's overall sodium intake. Hypokalemia may occur in patients with low potassium reserves or in those who are receiving concomitant medications that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Leukopenia and neutropenia may occur, especially during prolonged therapy. Therefore, periodic assessments of hematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions (seizures) may occur when high doses are administered, especially in patients with impaired renal function (see Adverse Reactions).
As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.
Use in Patients with Hepatic Impairment: See Dosage & Administration.
Renal Impairment: Due to its potential nephrotoxicity (see Adverse Reactions), piperacillin/tazobactam should be used with care in patients with renal impairment or in hemodialysis patients. Intravenous dosages and administration intervals should be adjusted to the degree of renal function impairment (see Dosage & Administration).
In a secondary analysis using data from a large multicenter, randomized-controlled trial when glomerular filtration rate (GFR) was examined after administration of frequently used antibiotics in critically ill patients, the use of piperacillin/tazobactam was associated with a lower rate of reversible GFR improvement compared with the other antibiotics. This secondary analysis concluded that piperacillin/tazobactam was a cause of delayed renal recovery in these patients.
Combined use of piperacillin/tazobactam and vancomycin may be associated with an increased incidence of acute kidney injury (see Interactions).
Effects on ability to drive and use machines: No studies on the effect of ability to drive or use machines have been performed.